MNH — Orthosis, Spondylolisthesis Spinal Fixation Class II
FDA product code MNH covers "Orthosis, Spondylolisthesis Spinal Fixation", a Class II medical device regulated under 21 CFR 888.3070. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MNH
- Device Class
- Class II
- Regulation Number
- 888.3070
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K162066 | reliance medical systems | Reliance Spinal Screw System | December 2, 2016 |
| K162801 | l and k biomed co | CastleLoc Spinal Fixation System | November 3, 2016 |
| K162143 | innovasis | FixxSure® X-Link | September 23, 2016 |
| K161151 | canwell medical co | Spinal fixation system | September 21, 2016 |
| K162189 | u and i corporation | ANAX 5.5 Spinal System | August 30, 2016 |
| K151362 | hung chun bio-s co | HC Spinal System | May 5, 2016 |
| K153404 | zavation | Zavation Spinal System | April 21, 2016 |
| K160020 | captiva spine | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | March 2, 2016 |
| K143013 | changzhou dingjian medical appliance co | Spinal Inner Fixation System | December 11, 2015 |
| K151695 | spineart | Romeo posterior osteosynthesis system | September 10, 2015 |
| K151116 | captiva spine | CapLOX II/TowerLOX Pedicle Screw System | June 26, 2015 |
| K150283 | republic spine | Republic Spine Dark Star Spinal System | April 29, 2015 |
| K142798 | medicrea international | PASS LP Spinal System | March 25, 2015 |
| K143417 | u and i corporation | ANAX 5.5 Spinal System | February 25, 2015 |
| K143377 | spinefrontier | PedFuse Pedicle Screw System | February 12, 2015 |
| K142957 | jiangsu ideal medical science and technology co | Ideal pedicle screw spinal system | January 30, 2015 |
| K142655 | chin bone technique | CB PROT II Posterior Spinal System | January 26, 2015 |
| K140359 | valorem surgical | MAXIMIS SPINAL FIXATION SYSTEM | January 7, 2015 |
| K142290 | suzhou kangli orthopaedics instrument co | KangLi pedical screw spinal system | November 24, 2014 |
| K134011 | changzhou dean medical instrument co | GENERAL SPINAL SYSTEM | September 3, 2014 |